Study into the safety and efficacy of eczema cream Clobetasone Butyrate.
- Conditions
- EczemaTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-004899-30-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 240
- Subjects with a diagnosis of eczema, fulfil the 3 follow items:
1) Erythema, papilla/water blister, Lichenification, skin damage with infiltration,
2) unknown reason, recurrent attacks;
3) itching in diseased skin
- Subjects must have body surface area (BSA) disease involvement of less than or equal to 10% as assessed by palm method
- Subject must present with moderate and above eczema as defined by a score greater than or equal to 3 using the investigators global assessment (IGA) of eczema severity.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- The subject presents with any systemic disorder or active skin disease (e.g. psoriasis) that would in any way confound interpretation of the study results or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area which could interfere with the assessment of lesions at screening.
- The subject has eczema restricted to the face, the feet or the hands only.
- The subject is indicated any anti-infectives drug for a current complication of overt bacterial, fungal and viral infection
- History of recent (<1 month) active or presence of current superficial skin infections of viral aetiology such as herpes simplex, or varicella.
- The subject has been exposed to below therapy within the set timeframe: Topical agents administered in the diseased skin, including emollient - 1 week; Systemic administration of anti-histamine agents - 2 week; Systemic administration of corticosteroid -4 week; Systemic administration of immunosuppressive drugs - 4 week; UV therapy -4 week
- Foreseeable intensive ultraviolet (UV) exposure during the study (solar or artificial). Subjects must not be exposed to intense direct sunlight for long periods, and must not use skin tanning devices (e.g. sunbed) for the duration of the study.
- History of clinically significant cardiovascular, pulmonary, gastrointestinal, liver, neurological, renal or haematological abnormalities.
- History of allergy to components of test medications to be used in the study.
- History of anaphylaxis (a sudden, potentially life-threatening systemic allergic reaction) to food, medications, insect venom, or latex.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study was to evaluate clinical efficacy and safety of 0.05% Clobetasone Butyrate Cream versus Placebo (cream base) applied to involved skin of subjects with eczema for 14 days.;Secondary Objective: Not applicable;Primary end point(s): Changes from baseline in EASI* score at Day 7 and Day 14<br><br>* EASI scores (The Eczema Area and Severity Index);Timepoint(s) of evaluation of this end point: Percentage reduction of EASI at Day 14
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Changes from baseline in IGA* graded score at Day 7 and Day 14<br>2. Changes from baseline VAS** score at Day 7 and Day 14<br>3. Subject-based assessment score of disease control at Day 7 and Day 14<br><br>*IGA (Investigators Global Assessment Scale)<br>** VAS (Visual Analog Scale);Timepoint(s) of evaluation of this end point: 1. Day 7 and Day 14<br>2. Day 7 and Day 14<br>3. Day 7 and Day 14